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  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

1 Recommendations

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1 Recommendations

1.1

Daratumumab plus bortezomib, lenalidomide and dexamethasone followed by daratumumab plus lenalidomide maintenance
should not be used as an option for untreated multiple myeloma in adults when an autologous stem cell transplant is suitable.

1.2

This recommendation is not intended to affect treatment with daratumumab plus bortezomib, lenalidomide and dexamethasone that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, daratumumab plus bortezomib, lenalidomide and dexamethasone followed by daratumumab plus lenalidomide maintenance would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether daratumumab plus bortezomib, lenalidomide and dexamethasone followed daratumumab plus lenalidomide maintenance is value for money in this population.

Why the committee made these recommendations

NICE is separately evaluating daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable.

Usual treatment for untreated multiple myeloma when an autologous stem cell transplant is suitable is:

  • daratumumab plus bortezomib, thalidomide and dexamethasone as induction and consolidation treatment, then

  • lenalidomide alone as maintenance treatment.

This evaluation looks at:

  • daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then

  • daratumumab plus lenalidomide as maintenance treatment.

Daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then daratumumab plus lenalidomide as maintenance treatment, has not been directly compared with daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation treatment followed by lenalidomide alone as maintenance treatment. The results of indirect comparisons suggest that the new combination may have similar effectiveness to usual treatment during induction and consolidation, but there is considerable uncertainty around its long-term benefits. Comparisons of daratumumab plus lenalidomide maintenance treatment with lenalidomide alone as maintenance treatment, suggest daratumumab plus lenalidomide increases how long people live and how long they have before their condition gets worse. But this is uncertain because comparisons of the full treatment sequence (including induction, consolidation and maintenance) were not conducted in the same trials.

There are uncertainties in the economic model. These include how it models subsequent treatments and how long people had treatment for.

Because of the considerable uncertainty around the long-term benefits of the new combination, it is not possible to determine the most likely cost-effectiveness estimates. But, they are likely to be higher than the range that NICE considers an acceptable use of NHS resources. So, daratumumab plus bortezomib, lenalidomide, and dexamethasone, followed by daratumumab plus lenalidomide, should not be used.